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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ZERO TIP¿ DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ZERO TIP¿ DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901050
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A visual analysis of the returned device found a small piece of foreign matter in between the original device pouch and a generic plastic bag packaging. The seal was intact and sterility was not compromised. The sealed device was packaged in a second layer generic bag at the distribution center, and it is most likely that the foreign matter was inserted during packaging for distribution. Therefore, the most probable root cause is "manufacturing: distribution process". An investigation has been initiated to address this issue. Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications. The device history record review found the device met all manufacturing specifications. A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a zero tip stone retrieval basket was to be used in a procedure performed on an unknown date. According to the complainant, during preparation, a black foreign object was observed to be inside the package. The foreign object was noted to be ¿like dirt¿ and was estimated to be about 2mm in size. The device was not used in a patient. The procedure was completed with another zero tip stone retrieval basket. There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a zero tip¿ stone retrieval basket was to be used in a procedure performed on an unknown date. According to the complainant, during preparation, a black foreign object was observed to be inside the package. The foreign object was noted to be ¿like dirt¿ and was estimated to be about 2 mm in size. The device was not used in a patient. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event.
 
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Brand NameZERO TIP¿
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7123250
MDR Text Key261913780
Report Number3005099803-2017-03793
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729469643
UDI-Public08714729469643
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063901050
Device Catalogue Number390-105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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